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Purpose

This study will enroll females who are ages 18 and older undergoing a laparoscopic or robotic, partial or full hysterectomy. Participants will be randomized to receive IV n-acetylcysteine or placebo during the first 60 minutes of their procedure. At various time points after the procedure patients will be asked to report their pain scores, and any pain medication taken.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Criteria

Inclusion

- Undergoing elective laparoscopic or robotic, full, or partial hysterectomy procedure

- 18 years of age and older

Exclusion

- Less than 40kg in weight

- Unable to provide written, informed consent

- History of an adverse or anaphylactoid reaction to acetylcysteine

- Active asthma, wheezing, or using inhaled bronchodilators

- Non-English speaking

- Insulin dependent diabetes if D5W is required

- Blood clotting disorders

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
IV Placebo 		Patients will receive: Placebo 0 mg/kg (placebo: 0.45% NaCl or D5W) through an IV that will run for 60 minutes at the start of the procedure.
  • Drug: IV Placebo
    Placebo 0 mg/kg (placebo: 0.45% NaCl or D5W) through an IV that will run for 60 minutes at the start of the procedure.
    Other names:
    • Placebo
Active Comparator
IV N-acetylcysteine 		Patients will receive: N-acetylcysteine (NAC) 150 mg/kg (Max dose 15,000 mg) through an IV that will run for 60 minutes at the start of the procedure.
  • Drug: IV N-acetylcysteine
    N-acetylcysteine (NAC) 150 mg/kg (Max dose 15,000 mg) through an IV that will run for 60 minutes at the start of the procedure
    Other names:
    • NAC

Recruiting Locations

Medical University of South Carolina
Charleston, South Carolina 29425
Contact:
Sylvia Wilson, MD
843-792-2322
wilsosh@musc.edu

More Details

Status
Recruiting
Sponsor
Medical University of South Carolina

Study Contact

Haley Nitchie, MHA
843-792-1869
nitchie@musc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.